Actively Recruiting
Study of Healthy Aging and Physical Function With Elamipretide
Led by David Marcinek · Updated on 2025-12-10
30
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
Sponsors
D
David Marcinek
Lead Sponsor
S
Stealth BioTherapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study will utilize a daily dose of elamipetide for 4 weeks and will screen a sufficient number of subjects for 30 subjects to enroll in the study. The planned duration of the study includes baseline measurement, followed by 4 weeks intervention period, a midpoint (2week ±3days) check-in phone interview, and post intervention visits that mirror the baseline visits. After the last injection, subjects will enter the 2-week follow-up period, concluded by the end-of-study contact.
CONDITIONS
Official Title
Study of Healthy Aging and Physical Function With Elamipretide
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 65 to 80 years
- Lower mitochondrial function with VO2peak ≤ 37.3 ml/kg/min for men or ≤ 25.7 ml/kg/min for women
- Ambulatory and able to perform daily activities without assistance
- Sufficient venous access for blood draws
- Willing and able to self-administer injections or have a caregiver who can
- Speak and read English
- No established daily exercise routine or physical hobby and agree not to start during the study
- Willing to avoid certain medications during the study including anti-seizure drugs, muscle mass or energy supplements, muscle relaxants, systemic steroids, immunosuppressives, and high-dose opioids
- No known allergies or adverse reactions to Fexofenadine
- Provide informed consent documentation
You will not qualify if you...
- Significant diseases or conditions that increase risk or affect study participation or results
- Severe kidney disease (eGFR <30 mL/min) or liver disease with elevated liver enzymes (>2x normal)
- History of rhabdomyolysis
- Hospitalization within 3 months for major atherosclerotic events or major medical conditions
- Current enrollment in another investigational drug or device study or incompatible medical research
- Participation in a clinical study with an investigational product within 30 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
S
Sophia Liu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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